Glabellar Lines
Conditions
Brief summary
To evaluate the efficacy and safety of HG102 for moderate to severe Glabellar Lines, non-inferiority compared to Botox® was confirmed and safety was evaluated.
Interventions
DRUGBotulinum Toxin Type A Injection [HG102]
Single administration, Day 0, 20 units
Single administration, Day 0, 20 units
Sponsors
Hugel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Subjects that fit all of the criteria below were selected for this clinical trial. 1. Male and female adults from 19 to 65 years old at the time of screening 2. Person with moderate or severe glabellar lines and have received Grade 2-3 according to Physician's Rating Line Severity at maximum frown 3. Person who understands and can comply to the process and visiting schedule of this clinical study 4. Person who gave spontaneous written consent to participate in this clinical study
Exclusion criteria
* Subjects that fit any of the criteria below were excluded from this clinical trial. 1. Person with infection, skin disease, or scar on forehead 2. Person with symptoms of facial palsy or blepharoptosis 3. Person with allergies or hypersensitive reaction history to the ingredients in the investigational product (botulinum toxin formula, serum albumin, etc.) 4. Person who were administered with similar medication within 12 weeks (botulinum toxin type A medication) or 16 weeks (botulinum toxin type B medication) 5. Pregnant and breast-feeding women, men and women in the childbearing age who are planning to get pregnant during the clinical study period, or do not agree to the suitable contraceptive methods 6. Person who participated in another clinical trial, or were given medication for other clinical trials within 4 weeks from screening of 5 times the half-life, which period may be longer 7. Other person who the investigator judges as inappropriate for the clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Responder rate of improvement in glabellar lines with Physician's rating line severity | Baseline to week 4 | Improvement rate of glabellar lines at maximum frown with Physician's rating line severity at 4 weeks post injection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Responder rate of improvement in glabellar lines with Physician's rating line severity | Baseline to week 8, 12, 16 | Improvement rate of glabellar lines at maximum frown with investigator's photo assessment at 8, 12, 16 weeks post injection |
| Responder rate of improvement in glabellar lines with investigator's photo assessment | Baseline to week 4, 8, 12, 16 | Improvement rate of glabellar lines at rest with Physician's rating line severity at 4, 8, 12, 16 weeks post injection |
| Independent photo evaluator-rated improvement rate of glabellar lines at rest | Baseline to week 4, 8, 12, 16 | — |
| Responder rate of improvement in glabellar lines with Subject's improvement assessment | Baseline to week 4, 8, 12, 16 | Improvement rate of glabellar lines with Subject's improvement assessment at 4, 8, 12, 16 weeks post injection |
| Participant-rated satisfaction after treatment | Baseline to week 4, 8, 12, 16 | Subject's satisfaction rate of improvement in glabellar lines at 4, 8, 12, 16 weeks post injection |
Countries
South Korea
Contacts
Primary ContactCho Long Park
Outcome results
None listed